U.S. FDA Title 21 CFR Part 11 Guidance Manual
U.S. FDA Title 21 CFR Part 11Guidance Manual
ApprovalsPrepared By:FunctionPrinted NameAuthorJulissa nPrinted NameIT TechnicalOperationsBrian FurnerDocument HistoryDocument RevisionRevisionDateRevision AuthorSummary of Changescri redcap 21cfrpart11 guidance manual 122016 001 d12/20/16Julissa AcevedoInitial Documentcri redcap 21cfrpart11 guidance manual 122016 002 d11/7/17Julissa AcevedoRevised OCR Address(last page)University of Chicago Center for Research Informatics REDCap Title 21 CFR Part 11 Guidance Manual2
TABLE OF CONTENTS21 CFR Part 11 Overview. 4When do I need to be 21 CFR Part 11 Complaint? . 4What are clinical trials?. 4What are the different types of clinical trials? . 4What are the phases of clinical trials? . 521 CFR Part 11 Electronic Signature . 5What are the electronic signature requirements? . 6How do I enable REDCap’s record locking and e-signature feature? . 6How it works . 6User Rights Steps . 6Record Locking Customization Steps . 7Lock Record Custom Text Example . 7How do I e-sign, lock, and unlock records? . 8How do I manage e-signed and locked records? . 8Where can I obtain further help? . 8University of Chicago Center for Research Informatics REDCap Title 21 CFR Part 11 Guidance Manual3
21 CFR Part 11 Overview Title 21 Code of Federal Regulations governs Food and Drugs. Part 11 is the Food and Drug Administration (FDA) guidelines on electronic records and electronicsignatures in the United States. Part 11 requires procedural controls (i.e. notification, training, SOPs, administration) and administrativecontrols in addition to the technical controls. REDCap is a compliant application containing the required technical requirements of a compliant system,namely e-signatures and record locking.When do I need to be 21 CFR Part 11 Compliant?According to FDA’s 2007 Guidance for Industry Computerized Systems Used in Clinical Investigations, if youare conducting a clinical trial and using computerized systems that contain any data that are relied on by anapplicant in support of a marketing application, including computerized laboratory information managementsystems that capture analytical results of tests conducted during a clinical trial. Applies to computerized systems that create source documents (electronic records) that satisfy therequirements in 21 CFR 312.62(b) and 812.140(b), such as case histories.Applies to recorded source data transmitted from automated instruments directly to a computerizedsystem (e.g., data from a chemistry autoanalyser or a Holter monitor to a laboratory information system).Applies to when source documentation is created in hardcopy and later entered into a computerizedsystem, recorded by direct entry into a computerized system, or automatically recorded by a computerizedsystem (e.g., an ECG reading).Does not apply paper records submitted electronically scanned 2 -not to (scanned, faxed copies).What are clinical trials?Biomedical or health-related research studies in human beings that follow a pre-defined protocol.Register trials at: www.ClinicalTrials.GovWhat are the different types of clinical trials? Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgeryor radiation therapy. Prevention trials look for better ways to prevent disease in people who have never had the disease or toprevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals,or lifestyle changes. Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease orcondition. Screening trials test the best way to detect certain diseases or health conditions. Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life forindividuals with a chronic illness.University of Chicago Center for Research Informatics REDCap Title 21 CFR Part 11 Guidance Manual4
What are the phases of clinical trials?The trials at each phase have a different purpose and help scientists answer different questions: In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) forthe first time to evaluate its safety, determine a safe dosage range, and identify side effects.In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) tosee if it is effective and to further evaluate its safety.In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,0003,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, andcollect information that will allow the experimental drug or treatment to be used safely.In Phase IV trials, post marketing studies delineate additional information including the drug's risks,benefits, and optimal use.21 CFR Part 11 Electronic SignaturePart 11, as it is commonly called, defines the criteria under which electronic records and electronic signaturesare considered trustworthy, reliable, and equivalent to paper records. Below are the specific criteria, and theassociated REDCap feature that meets said criteria.Electronic Signature Part 11.3: A computer data compilation of any symbol or series of symbols executed,adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwrittensignature.REDCap: Defined by e-signature actionElectronic Record Part 11.3: Any combination of text, graphics, data, audio, pictorial, or other informationrepresentation in digital form that is created, modified, maintained, archived, retrieved, or distributed by acomputer system.REDCap: E-Record is defined as the form metadata data entered e-signatureSignature/Record Linking Part 11.70: Electronic signatures and handwritten signatures executed to electronicrecords shall be linked to their respective electronic records to ensure that the signatures cannot be excised,copied, or otherwise transferred to falsify an electronic record by ordinary means.REDCap: Defined by record locking processSignature Manifestations Part 11.50: Signed e-records shall contain information associated with the signingthat clearly indicates:1. The printed name of the signer.2. The date and time when the signature was executed;.3. The meaning (such as review, approval, responsibility, or authorship) associated with the signature.REDCap: Defined by e-signature and locking management pageUniversity of Chicago Center for Research Informatics REDCap Title 21 CFR Part 11 Guidance Manual5
What are the electronic signature requirements?If your project is using e-signatures for 21 CFR Part 11 projects, the study personnel must adhere to thefollowing requirements: Before an electronic signature can be established, the study site will verify the identity of the individual.Each electronic signature will be unique to one individual and will not be reused by, or reassigned to,anyone else.Persons using electronic signatures shall, prior to or at the time of use, certify to the agency that theelectronic signatures in their system are intended to be the legally binding equivalent of traditionalhandwritten signatures.Persons using electronic signatures shall, upon agency request, provide additional certification ortestimony that a specific electronic signature is the legally binding equivalent of the signer’s handwrittensignature.How do I enable REDCap’s e-signature and record locking module?REDCap e-signatures are an extension of the record locking/unlocking functionality. Once a data collectioninstrument has been locked for a given record in the project, a person with e-signature privileges may thenapply an e-signature to that form. The e-signature option appears as a check box that says E-signature, whichappears just above the Save buttons and immediately below the Locked check box.How it works: Although locking a record prevents its data from being modified, the e-signature goes a stepfarther, and serves as the equivalent of a handwritten signature. If a record has been e-signed, then it denotesthat its data has been both locked (to prevent further changes) and authorized (i.e. by a user with e-signatureprivileges). By default, any user with Lock/Unlock privileges will be able to see the Lock option at the bottomof the data collection instrument, although other users will not see this option. Once a form is locked for arecord, the form will display (for all users) the time it was locked and the user who locked it, and all fields onthe form will be disabled/read-only until someone with Lock/Unlock privileges unlocks the form. It is alsoimportant to note that anyone with locking privileges (even if lacking e-signature authority) will negate the esignature on a form when unlocking the record, after which data changes can be made to the record. The esignature can be re-applied after such data changes. For any given record, an e-signature can be saved andnegated on a form an unlimited number of times. When saving an e-signature, a user will be asked to entertheir username and password for verification. If the username/password verification fails three times in a row,the user will be automatically logged out of REDCap.To enable the module, follow the User Rights steps and Record Locking Customization steps below.User Rights Steps:1. Under the project’s Applications left-hand menu, click on ‘User Rights’.2. Click on your username and click ‘Edit User Privileges’.3. Scroll to the section ‘Settings pertaining to record locking and E-signatures:’.4. Click the box for ‘Record Locking Customization’ and the circle for ‘Locking / Unlocking with E-signatureauthority’.5. Click ‘Save Changes’.University of Chicago Center for Research Informatics REDCap Title 21 CFR Part 11 Guidance Manual6
Record Locking Customization Steps:1. Navigate to the project’s Applications left-hand menu and click on ‘Record Locking Customization’.2. For all of the project’s instruments (forms), click the box ‘Display the Lock option for this instrument?’.3. Enter text to be displayed when the record is locked in the box ‘Lock Record Custom Text‘.4. Click 'Save'.Lock Record Custom Text Example:“My dated signature confirms that I have personally examined all of the available data recorded forthis electronic Case Report Form for completeness and accuracy.All information entered by me and/or by my colleagues is correct to the best of my knowledge.Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I,Principal Investigator of the “TrialName” under the auspices of the FDA, intend that this electronicsignature is to be the legally binding equivalent of my handwritten signature.To this I do attest by supplying my username and password and clicking the button marked Save.”University of Chicago Center for Research Informatics REDCap Title 21 CFR Part 11 Guidance Manual7
How do I e-sign, lock, and unlock records?To e-sign and lock a record:1. Go to the Form Status section of the form.2. Set record status (Incomplete, Unverified, or Complete).3. Check the box ‘Lock’.4. Check the box ‘E-Signature’.5. Click ‘Save Record’.6. Enter username and password.7. Click ‘Save’.To unlock a record:1. Click ‘Unlock form’. Note: Previous e-signature is negated, and form will need to be resigned.2. Click ‘Unlock’ to ‘Unlock Form’ confirmation message3. Enter new data or make changes to record.4. Click ‘Save Record’.5. Check the box ‘Lock’.5. Check the box ‘E-Signature’.6. Click ‘Save Record’.7. Enter username and password.8. Click ‘Save’.How do I manage my e-signed and locked records?The table below displays all existing records in the project with their status as locked or e-signed for all datacollection instruments. Forms that do not allow locking (if designated on the Record Locking Customizationpage) will not be displayed below. If a form has been designated not to display the e-signature option but stillallows locking, then it will display 'N/A' for that form's e-signature status. You may use the 'Actions' links tofilter the table in various ways to show or hide rows based on criteria related to its locking or e-signaturestatus. You may click the 'View Record' link to view that record on the data collection instrument, which willopen in a new window. If you would like to export the table as a file in CSV format, simply click the link below.University of Chicago Center for Research Informatics REDCap Title 21 CFR Part 11 Guidance Manual8
Steps:Navigate to the project’s Applications left-hand menu, and click on ‘E-signature and Locking Mgmt’.Where can I obtain further help?REDCap SupportCenter for Research InformaticsThe University of ChicagoDivision of Biological SciencesThe Shoreland, Suite 1D5454 S. Shore DriveChicago, IL 60615Phone: 773-834-8475redcap@rt.cri.uchicago.eduOffice of Clinical ResearchThe University of ChicagoDivision of Biological Sciences5841 S. Maryland Ave.I-625, MC 7132Chicago, IL 60637Phone: 773-834-1238Fax: 773-834-0659University of Chicago Center for Research Informatics REDCap Title 21 CFR Part 11 Guidance Manual9
University of Chicago Center for Research Informatics REDCap Title 21 CFR Part 11 Guidance Manual 4 21 CFR Part 11 Overview Title 21 Code of Federal Regulations governs Food and Drugs. Part 11 is the Food and Drug Administration (FDA) guidelines on electronic records and electronic signat
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